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Have you had the experience of guiding a new product through concept, development, and final design, and, while you are preparing the product for US introduction, you suddenly stop dead. It seems FDA has decided your product is a medical device!
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2-day In-person Seminar:
Knowledge, a Way Forward…
US Medical Device Regulation
San Diego
December 17th & 18th, 2015
9:00 AM to 6:00 PM
Anna Longwell Principal, Longwell and Associates
Price: $1,295.00
(Seminar for One Delegate)
Register now and save $200. (Early Bird)
**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
Price
Anna Longwell is currently principal attorney of the
Palo Alto Law firm, Longwell and Associates, which
specializes in Food and Drug law. The firm has expertise
in US FDA expectations, regulation and law, affecting
the development and ultimate marketing of new medical products, drugs,
devices and biologics. They have served the regulatory needs of large
(>$2 billion/year) divisions of Fortune 500 companies, and small (4
person) biotech start-ups.
Global
CompliancePanelW
ho
will b
en
e
t ?
People who are Working in non Regulatory or QA Areas of Medical Device Companies
People who are Interested in Starting a Company to Sell Health-related Products
People who are Interested in financing a Health Care Company
People who are Interested in Selling Medical Devices
Who will benet ?
Break Overnight
Clinical Trials
IDE
Other
Export for trials
Common problems in trial design and management
Post marketing
QSR
CAPA
Reporting
Inspections
Export for foreign markets
Pop quiz
Give quiz
Discuss questions and answers
Overview
2-day In-person Seminar:
US Medical Device Regulation
Global
CompliancePanel
AGENDA:
Day One Day Two
Lecture 1:
What is a device
How can you tell if your product is a medical device
Regulation and guidance and the role of each
Determining your classification
Lecture 2:
Pre-market
Design control
Pre-submission meetings
Lecture 3:
Marketing submissions
PMA
510(k)
De novo
Lecture 4:
The "different" products
Combination Products
IVDs and LDTs
Software
Lecture 1:
Clinical Trials
IDE
Other
Export for trials
Common problems in trial design and management
Lecture 2:
Post marketing
QSR
CAPA
Reporting
Inspections
Export for foreign markets
Lecture 3:
Pop quiz
Give quiz
Discuss questions and answers
Have you had the experience of guiding a new product
through concept, development, and final design, and, while
you are preparing the product for US introduction, you
suddenly stop dead. It seems FDA has decided your product
is a medical device!
The basic definition of a medical device is extremely broad,
including "instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or
related article, including any component, part, or accessory,
which is...intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment or prevention
of disease..." If the product 's intended us has some
relationship to health, and the product is not a drug, it's
possible to define it as Medical Device. Fortunately for
publishers, medical textbooks and medical journals have not
yet been considered to be medical devices. What has been
determined to be medical devices by FDA are laboratory
developed tests, and stand-alone software that keeps track
of patient's condition, that is, LIMS and Electronic Health
Records. If you are developing, or considering developing, or
considering financing development, you need to have some
basic understanding of US medical device law, and this 1.5
day session is designed to give you that.
Why should you attend? AGEND
AAG
ENDA
AGEND
A
AGEND
A
2-day In-person Seminar: Global
CompliancePanel
www.globalcompliancepanel.com
Kindly get in touch with us for any help or
information.
Look forward to meeting you at the seminar
GlobalCompliancePanel
What You will get
Special price on future seminars by
GlobalCompliancePanel.
Networking with industry's top notch professionals
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1 Learning Objectives
2 Participation certificates
Interactive sessions with the US expert
Post event email assistance to your queries.
Special price on future purchase of web
based trainings.
Special price on future consulting or expertise
services.
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Seminar Kit – includes presentation handout,
ID card, brochure, trainings catalog, notepad
and pen.
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Contact Information: Event Coordinator
NetZealous LLC, DBA TrainHR
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA
Toll free: +1-800-447-9407
Fax: 302 288 6884
Email: [email protected]
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Group Participation
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1 Credit Card: Use the Link to make Payment by
Visa/Master/American Express card click on the
register now link
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NetZealous DBA GlobalCompliancePanel and
mailed to 161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA
PO: Please drop an email to
[email protected] or call the
our toll free +1-800-447-9407 for the invoice and
you may fax the PO to 302 288 6884
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US Medical Device Regulation
